(217 days)
No
The description details a mechanical process (pressure swing adsorption) controlled by a motorized valve and compressor, with no mention of AI or ML terms or functionalities.
Yes
The device is explicitly stated to be "intended solely for medical use in oxygen therapy programs" and its function is to provide "a high level of inspired oxygen," which is a therapeutic intervention.
No
The device is an oxygen concentrator used for oxygen therapy, not for diagnosing medical conditions. Its function is to provide oxygen-enriched gas.
No
The device description clearly outlines a physical, AC-powered oxygen concentrator with mechanical components (compressor, valve) and a significant weight (50 pounds). It is not solely software.
Based on the provided text, the Mark 5 Nuvo (M5C5) Oxygen Concentrator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "medical use in oxygen therapy programs under the supervision of a physician." This describes a therapeutic device that provides oxygen directly to a patient.
- Device Description: The description details how the device physically separates oxygen from ambient air and delivers it. It does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is the core function of an IVD.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic testing.
In summary, the Mark 5 Nuvo (M5C5) Oxygen Concentrator is a medical device used for delivering oxygen to a patient, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Mark 5 Nuvo (M5C5) Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.
Product codes
CAW
Device Description
The Mark 5 Nuvo (M5C5) oxygen concentrator is an AC powered device that provides a high level of inspired oxygen by separating oxygen from ambient air utilizing pressure swing adsorbers (PSA). Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized rotary 4-way valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90 ±3% at a flow rate of 5 l/min ±10%. It is not a life-supporting, life-sustaining or sterile device. The Mark 5 Nuvo (M5C5) oxygen concentrator is a durable, reusable, semi-portable unit weighing approximately 50 pounds [23 kg]. The device is available in both 115V and 230V models that have been designed and validated according to applicable requirements of EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999 as appropriate to the area of usage. The Mark 5 Nuvo (M5C5) oxygen concentrator is intended to be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested to applicable requirements EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999 as appropriate to the area of usage. Testing was conducted in June 2003 at Intertek Testing Services NA Inc. located at Duluth, GA. and documented in report numbers 3040276-27-1-1and 3040276A.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the text string "K032509" in a handwritten style. The text is oriented diagonally, running from the bottom left to the upper right corner of the image. The characters are written in a simple, sans-serif font, and the overall impression is that of a quick, informal notation.
MAR 1 8 2004
510(k) Summary
| 510(k)
Summary | This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of 21 C.F.R. § 807.92. | | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------------------------|
| Submitter | Nidek Medical Products, Inc. | | |
| Contact Person | Jennifer McWilliams, Quality Assurance Manager
3949 Valley East Industrial Drive
Birmingham, AL 35217
Phone (205) 856-7200 ext. 215
Fax (205) 856-0563
jmcwilliams@nidekmedical.com | | |
| Date Prepared | August 12, 2003 | | |
| Name | Mark 5 Nuvo (M5C5) | | |
| Classification
Names | Oxygen Concentrator | | |
| Device
Classification | Classification: Generator, Oxygen Portable
Classification Panels: Anesthesiology
Regulation Number: 21CFR 868.5440 | | |
| Predicate
Device(s) | | | |
| | Mark-5 (M5C5) Concentrator
Model 590 Oxygen Concentrator | K883591
K895141 | November 2, 1988
October 31, 1989 |
| Performance
Standards | Performance standards have not been established by the FDA under
section 514 of the Federal, Food, Drug and Cosmetic Act | | |
| Device
Description | The Mark 5 Nuvo (M5C5) oxygen concentrator is an AC powered
device that provides a high level of inspired oxygen by separating
oxygen from ambient air utilizing pressure swing adsorbers (PSA).
Air is drawn into the device with a piston-type compressor and
exposed to molecular sieve adsorbent that selectively retains nitrogen
and other components until they are released when the pressure is
vented to the atmosphere. This cycle is controlled by a motorized
rotary 4-way valve and protected from over pressurization by the
compressor's pressure relief valve. The device provides a nominal
oxygen enriched gas concentration of 90 ±3% at a flow rate of 5
l/min ±10%. It is not a life-supporting, life-sustaining or sterile
device | | |
| Device Description Continued | The Mark 5 Nuvo (M5C5) oxygen concentrator is a durable, reusable, semi-portable unit weighing approximately 50 pounds [23 kg]. The device is available in both 115V and 230V models that have been designed and validated according to applicable requirements of EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999 as appropriate to the area of usage. The Mark 5 Nuvo (M5C5) oxygen concentrator is intended to be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device. | | |
| Indications for Use | The Mark 5 Nuvo (M5C5) Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life. | | |
| Technological Characteristics | The Mark 5 Nuvo (M5C5) contains features and functions that are similar to the Mark-5 (M5C5) concentrator. The following table briefly describes the proposed changes that do not affect the intended use or alter the fundamental scientific technology of the device. | | |
| | Component | Predicate Device | Proposed Device |
| | Compressor Cooling | Squirrel Cage Blower | Tubeaxial Fan |
| | Molsiv Adsorbent | MO2 | OxySiv |
| | Flow Control | Selectable Fixed-Orifice Valve | Flow Meter (Thorpe Tube) |
| | Outlet Pressure | 9 PSI | 7 PSI |
| | Circuit Breaker | none | 10 Amp |
| | Cabinet Dimensions | Rectangular Design | Contoured Design |
| | Compressor Support | Natural Rubber Isolators | Steel Springs |
| | Labeling | Words | Symbols |
| | Pressure Measurement | Pressure Switches | Pressure Sensor |
| Nonclinical Performance | The device was tested to applicable requirements EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, and CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999 as appropriate to the area of usage. Testing was conducted in June 2003 at Intertek Testing Services NA Inc. located at Duluth, GA. and documented in report numbers 3040276-27-1-1and 3040276A. | | |
| Conclusion | The Mark 5 Nuvo (M5C5) is substantially equivalent to the legally marketed Mark-5 (M5C5) concentrator. | | |
.
1
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2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a bird-like figure, possibly an eagle, with three wing-like shapes above a wavy line, suggesting water or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2004
Ms. Jennifer McWilliams Quality Assurance Manager Nidek Medical Products, Incorporated 3949 Valley East Industrial Drive Birmingham, AL 35217
Re: K032509
Trade Name: Mark 5 Nuvo (M5C5) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: February 18, 2004 Received: February 20, 2004
Dear Ms. McWilliams:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Security premation is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule, to regary manetee to fithe Medical Device Amendments, or to commerce prior to May 20, 1970, the enacember with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costience Act (Act) that to not require appro the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls pro You may, merefore, market the devrees, saloject to an all registration, listing of the general controls provisions of the Fisc labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see aboro) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional occurrents, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Productions
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualled of a sualies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decemmancia in administered by other Federal agencies. You must on and lists or any Federal statures and regulations daminders but not limited to: registration and listing (21 let comply with an the Act s requirements, morealing, arenes, and manufacturing practice requirements as set
3
Page 2 -- Ms. Jennifer McWilliams
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
tinger
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Item #7
Indications for Use
510(k) Number (if known): K032509
Mark 5 Nuvo (M5C5) Device Name:
The Mark 5 Nuvo (M5C5) Oxygen Concentrator is Indications for Use: intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/O ಗಿ
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE: ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sottwle
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K032509
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